Aug 22 - 4:39
Designation According to the notice published by the Medical Devices Division of CDSCO, the regulating authority registered six notified bodies, authorizing them to perform medical device manufacturing site audits, the...
Aug 20 - 6:14
The adoption of Medical Device Regulation is a new step towards the improvement of the medical device regulatory framework. Regulation 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical...
May 17 - 4:59
Ireland medical device regulations are unified with other European Union countries and follow the same EU MDR and IVDR regulation. However, each country has their own Regulatory Authority (RA). In the case of Ireland,...
Apr 18 - 4:23
The US Medical Device regulating authority, the Food and Drug Administration (FDA), has issued a Safety Communication to warn all potential users on risks associated with the use of unapproved diagnostic medical...
Apr 12 - 5:57
Medical devices in Greece are regulated by The National Organization for Medicines (EOF), a public entity of the Ministry of Health. Greece, as a member of European Union, classifies medical devices according to their...
